Mosquirix : Malaria Vaccine

           The World Health Organisation (WHO) endorsed the “Mosquirix “ world's first Malaria Vaccine in the hope that it will spur stalled efforts to curb the spread of the parasitic disease.

           Malaria is a life-threatening disease caused by parasites that are transmitted to people through the bites of infected female Anopheles mosquitoes. It is preventable and curable.

 

• About:
  • RTS,S/AS01, trade name Mosquirix, is an injectable vaccine targeting P. falciparum, the most prevalent malaria strain in Africa. It is the first and only vaccine to show partial protection in young children.
    
    • It was developed by British drugmaker GlaxoSmithKline in 1987.
  • The active substance in Mosquirix is made up of proteins found on the surface of the Plasmodium falciparum parasites (PFP).
    • RTS,S aims to trigger the immune system to defend against the first stages of malaria when the PFP enters the human host’s bloodstream through a mosquito bite and infects liver cells.
  • It also helps protect against infection of the liver with the Hepatitis B virus.
• Potency:
  • The vaccine's effectiveness at preventing severe cases of malaria in children is only around 30%, but it is the only approved vaccine.
    • The European Union's drugs regulator approved it in 2015, saying its benefits outweighed the risks.
  • Its side effects are rare, but sometimes include a fever that may result in temporary convulsions.
• Challenges:
  • Inconvenient: A child must receive four injections before age 2, sometimes at intervals that do not match the routine vaccine schedules for most other diseases.
  • Partly Effective: Testing in more than 10,000 African children from 2009 to 2014 showed that, even after four doses, the vaccine prevented only about 40% of detectable malaria infections.
  • Not Long Lasting: It is unclear how long even those relatively low levels of protection last; previous trials followed vaccinated children for four years. Experts also worry that parents whose children are vaccinated will become less vigilant about using mosquito nets, and less likely to seek medical care when their children develop fevers.
  • Develop Resistance: The vaccine reduced the occurrence of severe malaria by about 30%, and the occurrence of severe anemia - a complication that often kills children - by about 60%. It did not protect well against parasite strains that were poor genetic matches, raising a concern that, over time, parasites could evolve resistance to the vaccine as they have to drugs.
• Burden of Malaria:
  • Global:
    • In 2019, there were an estimated 229 million cases of malaria worldwide, and the estimated number of malaria deaths that year stood at 4,09,000.
      • Children aged under 5 years are the most vulnerable group affected by malaria in 2019, they accounted for 67% (2,74,000) of all malaria deaths worldwide.
  • India:
    • In 2019, India had an estimated 5.6 million cases of malaria compared to about 20 million cases in 2020, according to WHO.
• Countries that Eliminated Malaria:
  • Over the last two decades, 11 countries have been certified by the WHO Director-General as malaria-free: United Arab Emirates (2007), Morocco (2010), Turkmenistan (2010), Armenia (2011), Sri Lanka (2016), Kyrgyzstan (2016), Paraguay (2018), Uzbekistan (2018), Algeria (2019), Argentina (2019), and El Salvador (2021).
    • Countries that have achieved at least 3 consecutive years of zero indigenous cases of malaria are eligible to apply for the WHO certification of malaria elimination.

 

GROUP I MAINS SCIENCE AND TECHNOLOGY

BIOPLASTICS ARE BEING PROPOSED AS A SAFE ALTERNATIVE TO PLASTICS. IN THIS CONTEXT, EXPLAIN THE DIFFERENT TYPES OF BIOPLASTICS AND ALSO EXPLAIN THE IMPACT OF BIOPLASTICS ON THE ENVIRONMENT.

         Bioplastics are biodegradable materials. They are developed from renewable resources like biomass. They used to reduce the problem of plastic waste.

Types of bioplastics:

• Cellulosed based plastics are made from wood pulp and they are used for making film materials such as wrappers.
• Thermo plastics are starch based plastics. They are used for production of drug capsules.
• Poly hydroxy butrate (PHB) is used for making
  bank notes and carpets etc.,
• Polymide II : It is prepared from vegetable oils and used for making oil and flexible pipes etc.,

Impact of Bioplastics on environment.

Positives :

• Bioplastics are better than petro plastics interms of fossil fuel consumption, energy, efficiency etc.,
• They are easy to recycle . They don't contain additives which are harmful to health.
  They donot change the flavour of the food contained.
• They reduce the carbon footprint because they do not consume the non renewable resources.
• They all ready used in Agriculture, textile, industry, medicine etc in Europe and USA for their ecological reason.

Negatives:

• All bioplastics are not biodegradable.
• In 2009, Central pollution control board tested the samples and found that only 40% of them are biodegradable.
• People cannot differentiate bioplastics from regular plastics in the trash.
• Bioplastics are inferior to petroplastcs in terms of cost and applicability.

          It is better for Alternative techniques which are more environmental friendly. Ex: Composting and making people aware about the importance of waste management and protecting environment.

17 INTERESTING FACTS ABOUT HUMAN BODY

1. Liver is the heaviest organ in our body, weighing about 1.6 kg.
2. Each day our heart beats normally over 1,00,000 times.
3. The normal temperature of our body is 37°C or 98° F
4. There are 206 bones in our skeleton. A newborn baby has 300 bones, out of which 94 bones join together as he or she grows.
5. Most people have 12 pairs of ribs. But one out of every 20 people has at least one extra pair.
6. An average man has about 5.5 litres of blood.
7. Each side of the brain controls the opposite side of the body.
8. The hair on our head usually lives for 2-6 year before dropping out.
9. The fastest muscles in our body are those that blink the eyelids. We can blink as fast as 200 times per minutes.
10. Our eyelids have the thinnest skin on our body (only 1 mm thick) while our soles have the thickest skin (about 3 mm thick)
11. It takes about 17 muscles to smile, but about 43 to frown.
12. The size and shape of a person’s nose can affect his or her voice.
13. The coronary heart disease is the most common cause of sudden death.
14. One brain cell may be connected to as many as 25,000 other brain cells.
15. A meal takes as long as 15 hours to pass through our whole digestive system.
16. Through blinking, we spend about half an hour of our walking day with our eyes closed
17. The thigh bone, called femur, is the longest and the largest bone in our body. The smallest bone is the stirrup bone in the middle ear.

THE BIOTECHNOLOGY REGULATORY AUTHORITY OF INDIA BILL, 2013

The Biotechnology Regulatory Authority of India Bill, 2013

• Bill will set up an independent authority
•  Authority will regulate products and processes of Biotechnology and certify that the product is safe
• Regulation

o   Research

o   Trails

o   Manufacture

o   Transport including import and export

o   Use

• Bill doesn’t specify for any liability, the tribunal and the court  will decide the liability
• Biotechnology

o   Is about manipulation of genetic structure of organisms. This results in change in specific traits

o   Ex: Bt Cotton which produces an insecticide that kills certain pests that eat it or production of synthetic insulin for human consumption

• Currently biotechnology is regulated by

o   Ministry of Environment and Forests

o   Department of Biotechnology under Ministry of Science and Technology

• Biotechnology is governed under the rules of The Environmental Protection Act 1986

How BRAI will work / the institutional setup?

• Field trials of the modified products (which could be organisms) will only be conducted after permission from BRAI
• For a drug or vaccine with elements of biotechnology, the Central Drugs Standard Control Organisation (CDSCO) will forward the application to BRAI to assess whether it is safe to proceed with a clinical trial. Clinical trials will continue to be regulated by the CDSCO under the Drugs and Cosmetics Act, 1940.
• The Bill amends the Food Safety and Standards Act, 2006, which regulates the manufacture, import, sale and distribution of food  items. The amendment mandates that food items with elements of biotechnology have to be approved by BRAI as safe for human consumption
• BRAI will not disclose confidential commercial information made available to it in an application for authorisation. This is regardless of anything contained in the Right to Information Act, 2005.
• BRAI will comprise of three units:

o   Risk Assessment Unit (RAU): The RAU will undertake science - based safety assessments of the applications (applications seeking authorisation for research, transport, import, manufacture or use of products and organisms of biotechnology)

o   Product Rulings Committee (PRC): the report of the RAU will be forwarded to the PRC and the PRC will make recommendations regarding the safety of the product or organism

o   Environmental Appraisal Panel (EAP): BRAI may refer an application to the EAP, in case of products or organisms having an environmental impact.

• BRAI will constitute an Enforcement Unit consisting of monitoring officers for enforcing its decisions
• the three regulatory divisions

o   agriculture, forest and fisheries

o   human health and veterinary products

o   industrial and environmental applications

• Each of these will be headed by a Chief Regulatory Officer (CRO)
• Disputes will be heard at Biotechnology Regulatory Appellate Tribunal
• Tribunal will have civil jurisdiction
• Appeal against the tribunal will be made in Supreme Court
• Tribunal will consist of 1 judicial member and 5 technical members having expertise in Biotechnology

Biotechnology Regulation Present Scenario

• Biotechnology has its benefits and drawbacks
• Benefits of this technology include the introduction of characteristics such as drought resistance, pest resistance, or high iron content in a plant
• Risks include adverse impact on the health of organisms that consum  these products, and the environment and biodiversity.
• Any regulatory structure for the sector will need to balance the benefits with the risks and ensure the safe use of biotechnology
• The Bill envisages an independent scientific risk assessment to be undertaken by experts in the field of biotechnology.
• Comparison of the current regulatory approval system under the 1989 rules with the regulatory approval system proposed under the Bill 

 

International Regulations

• The Convention on Biological Diversity and the Cartagena Protocol on Biosafety mandate rigorous scientific regulation to ensure safe use of biotechnology.
• In USA and Canada, the government departments of agriculture, health, environment and food regulate biotechnology. Both countries use existing laws and agencies rather than creating a specialized regulatory mechanism.
• Australia has set up an independent regulator

Determination of Liability

• The primary function of liability regimes is to provide compensation to affected parties and incentivise the industry to minimise the risks of adverse impact. There are different types of liability regimes. In some cases, liability is specified in a law (statutory liability). In other cases, courts decide that the polluter should compensate.
• The Bill does not specify any liability regime. Therefore, it will remain open to the courts to determine the general civil liability arising out of any adverse impact of modern biotechnology.
• The Nagoya Supplementary Protocol has stated that countries should have a liability regime for living modified organisms
• USA and Canada have not specified any liability
• Australia and Norway in its statute regulating biotechnology, has specified strict liability for genetically modified organisms

Recommendation of Various Committees

Swaminathan Task Force on Agriculture

• An autonomous regulatory commission should be created with expertise in Biotechnology and Biosafety Work of the committee (testing, evaluation and approval) should be scientific
• Agriculture is a state subject, a state body should be there to bring cohesiveness with the centrl body

CD Mayee Committee on Bt-Cotton

• Regulatory Committee should have technical expertise
• Agriculture is a state subject so state agricultural department and institutions as universities should be involved in testing, evaluation, approval and monitoring of field trials

Mashelkar Committee on Recombinant Drugs

• Overlap in approval process of GEAC and Drugs Controller General of India has led to ambiguity
• An independent regulator is needed

Supreme Court on Agriculture

• Independent regulatory system is required
• Regulators should implement a robust scientific review mechanism through a dedicated and qualified team
• Mandatory consultation should be held with states to seek permission for field trials. Most of the responsibility for the maintenance and operation at the field level should be given to the states.

Controversy

• Though the Bill brings the regulation of biotechnology under the powers of the Union. So, the states are objecting that Union is trying to infringe the state’s right for example in case of agriculture. The Centre claims that the states will still have the powers to intervene in issues like GM technology as agriculture is something that belongs to the State list
• The draft Bill attempts to bypass the Right to Information Act (RTI) under the garb of being “Confidential Commercial Information”. Activists say that biosafety information cannot be confidential and the Supreme Court has already set a precedent for this in the Bt Brinjal case. RTI has time and again helped activists and civil society expose or get information on field trials of GMOs at various areas, which will be impossible if BRAI becomes law.
• Conflict of Interest: The ministry of Science and Technology, which is in charge of promoting genetically modified organisms in India like it promotes any other science and technology venture, is the regulating authority as the draft Bill proposes to set up the BRAI under the ministry. Activists view that as a clear case of conflict of interest. The Bt Brinjal file sailed through various ministries, including science and technology, without a hitch. It was stalled by the environment ministry alone. Now the government is trying to give a fast track single window clearance for genetically modified organisms through this Bill
• Deviation from Task Force Report: The task force on agricultural biotechnology, headed by M S Swaminathan, laid six cornerstones. They include well being of farming families, economic and environmental sustainability, bio-security and trade security. None of these has been taken into account while drafting the Bill.